Systems and Methods for Bariatric Therapy

ABSTRACT

The present invention provides bariatric therapy systems. One system includes a gastrointestinal implant device and a delivery mechanism therefor. The device can include a sleeve for placement into a small intestine and to minimize absorption of nutrients by its walls. An anchoring mechanism coupled to a proximal end of the sleeve and designed to be secured within the stomach can be provided. A passageway extending through the anchoring mechanism and the sleeve can also be provided, along which food can be directed from the stomach to the small intestine. The delivery mechanism can include a housing for accommodating the device, and a deploying balloon situated within the housing and which can be actuated to direct the sleeve of the device from within the housing to the site of implantation. Methods for providing bariatric therapy are also provided by the present invention.

RELATED APPLICATIONS

This application is a divisional application of U.S. application Ser.No. 13/007,344 filed Jan. 14, 2011, which claims priority to and thebenefit of U.S. Provisional Application No. 61/295,012 filed Jan. 14,2010, U.S. Provisional Application No. 61/300,663 filed Feb. 2, 2010,and U.S. Provisional Application No. 61/360,653 filed Jul. 1, 2010,which applications are incorporated herein by reference in theirentireties.

This application is also related to U.S. application Ser. No.13/089,722, filed on Apr. 19, 2011, which application is incorporatedherein by reference in its entirety.

BACKGROUND

According to the Center for Disease Control (CDC), over sixty percent ofthe United States population is overweight, and almost twenty percentare obese. This translates into about 38.8 million adults in the UnitedStates with a Body Mass Index (BMI) of 30 or above. The BMI is generallydefined as the weight (e.g., in kilograms) of an individual divided bythe height (e.g., in meters) of the individual, squared. To beconsidered clinically, morbidly obese, one must meet one of threecriteria: BMI over 35, 100 lbs. overweight, or 100% above ideal bodyweight. There is also a category for the super-obese for those weighingover 350 lbs.

Obesity is thus an overwhelming health problem in the U.S. Moreover,because of the enormous strain associated with carrying this excessweight, organs are affected, as are the nervous and circulatory systemsin an individual who is overweight or obese. In 2000, the NationalInstitute of Diabetes, Digestive and Kidney Diseases (NIDDK) estimatedthat there were 280,000 deaths directly related to obesity. The NIDDKfurther estimated that the direct cost of healthcare in the USassociated with obesity is $51 billion. In addition, Americans spendapproximately $33 billion per year on weight loss products. In spite ofthis economic cost and consumer commitment, the prevalence of obesitycontinues to rise at alarming rates. From 1991 to 2000, obesity in theUS grew by about 61%. Not exclusively a US problem, worldwide obesityranges are also increasing dramatically.

There have been many attempts in the past to surgically modify anatomiesof a patient to address the consumption problem by reducing the desireto eat. Stomach staplings, or gastroplasties, in order to reduce thevolumetric size of the stomach, therein achieving faster satiety, wereinitially performed in the 1980's and early 1990's. Although able toachieve early weight loss, sustained reduction in connection withgastroplasties was not obtained. The reasons are not all known, but arebelieved to be related to several factors. One of which is that thestomach stretches over time, thereby increasing volume, whilepsychological drivers motivate patients to find creative approaches toliterally eat around the smaller pouch.

Space-occupying gastric balloons have also been used to treat obesitysince the 1980's. One such balloon is described by Garren et al. (U.S.Pat. No. 4,899,747 Method and apparatus for treating obesity). Gastricballoons are generally designed to decrease the functional volume of thestomach.

Similarly, intestinal sleeves are also being used for obesity treatment(Levine et al., U.S. Pat. No. 7,347,875 Methods of treatment using abariatric sleeve; Levine et al. U.S. Pat. No. 7,025,791 Bariatricsleeve). These sleeves consist of an anchoring mechanism that attachesat one end of a thin walled plastic sleeve and extends from the pylorusto allow the sleeve to extend past the Ligament of Treitz. Intestinalsleeves function to decrease absorption from the portion of bowelcovered by the sleeve. Presently, a guidewire is advanced into thepatient's jejunum under fluoroscopic guidance (Gersin K S, Keller J E,Stefanidis D, et al. Duodenal jejuna bypass sleeve: A totally endoscopicdevice for the treatment of morbid obesity. Surg Innov 2007:14; 275). Agastroscope is then used to deploy the stent-like anchor in the pylorus,and gastroscopic instruments; e.g. graspers, are used to hold the sheathand advance it along the intestine to the Ligament of Treitz. However,complications often associate with delivery of intestinal sleeves. Inaddition, the sleeves are difficult to manipulate, and especially thecurrent methods for advancing the sleeves along the intestine are timeconsuming and inefficient.

In another approach, an open bariatric surgical procedure known as the“Roux-en-Y” procedure, a small stomach pouch is created by stapling partof the stomach together.

This small pouch can limit how much food an individual can eat. Inaddition, a Y-shaped section of the small intestine is attached to thepouch to allow food to bypass the duodenum as well as the first portionof the jejunum. This causes reduced calorie and nutrient absorption.Common problems associated with Roux-en-Y include pouch stretching,where the stomach gets bigger overtime and can stretch back to itsoriginal size over time; a breakdown of staple lines where the staplesfall apart and reverse the procedure; and a leakage of stomach contentsinto the abdomen (this is dangerous because the acid can eat away otherorgans. In addition, as the Roux-en-Y procedure requires open surgery,it is a painful, time-consuming operation and requires relatively longrecovery time.

Accordingly, it would be desirable to have an effective system forbariatric therapy, reducing the harmful side effects such as painfulsurgical operations. In particular, there is a need for effectivesystems and delivery mechanisms for bariatric therapy that can minimizecomplications and recovery time, reduce operation time and resources,and improve therapy efficiency, success rate, and safety.

BRIEF DESCRIPTION OF DRAWINGS

FIGS. 1A-1B illustrate an Intestinal Sleeve Delivery system inaccordance with an embodiment of the present invention.

FIGS. 2A-2B illustrate another Intestinal Sleeve Delivery system inaccordance with an embodiment of the present invention.

FIGS. 3A-3B illustrate an Intestinal Sleeve Delivery system from aneverted position to a deployed position in accordance with an embodimentof the present invention.

FIG. 4 illustrates still another Intestinal Sleeve Delivery system inaccordance with an embodiment of the present invention.

FIGS. 5A-5B illustrate a further Intestinal Sleeve Delivery system froman everted position to a deployed position in accordance with anembodiment of the present invention.

FIG. 6 illustrates still a further Intestinal Sleeve Delivery system ina deployed position in accordance with an embodiment of the presentinvention.

FIGS. 7-8 illustrate various stages of everting a Intestinal SleeveDelivery system in accordance with an embodiment of the presentinvention.

FIGS. 9-13 illustrate still another Intestinal Sleeve Delivery system inaccordance with an embodiment of the present invention.

SUMMARY OF THE INVENTION

The present invention provides, in an embodiment, a gastrointestinalimplant device. The gastrointestinal implant device can include a sleevefor placement into a small intestine and to minimize absorption ofnutrients by a wall of the small intestine. The sleeve, in anembodiment, may be made from a sufficiently flexible material to permitthe sleeve to move between an inverted position and an everted position.In certain embodiments, the sleeve may be made from a material havingsubstantially low permeability, so as to minimize absorption ofnutrients from the digested food by the wall of the small intestine. Thegastrointestinal implant device, in an embodiment, can also include ananchoring mechanism coupled to a proximal end of the sleeve and designedto be secured within a stomach, so as to allow the sleeve to securelyextend into the small intestine. In some embodiments, the anchoringmechanism is designed to reduce functional volume of the stomach. Theanchoring mechanism, in one example, can be an inflatable balloonsufficiently large to prevent the inflatable balloon from entry into thesmall intestine. To that end, the anchoring mechanism may include a portfor inflating the anchoring mechanism. The anchoring mechanism mayalternatively be a self-expanding frame which, upon expansion, can besubstantially frustoconical in shape for securing against a wall of thestomach, while allowing the stomach to maintain a substantially fullfunctional volume. The gastrointestinal implant device, in anembodiment, can further include a passageway extending through theanchoring mechanism and the sleeve, and along which digested food can bedirected from the stomach into the small intestine.

The present invention further provides, in another embodiment, abariatric therapy system. The system can include a gastrointestinalimplant device. The device, in an embodiment, can include a sleeve forplacement into a small intestine and to minimize absorption of nutrientsby a wall of the small intestine. The device can also include ananchoring mechanism coupled to a proximal end of the sleeve and designedto be secured within a stomach so as to allow the sleeve to securelyextend into the small intestine. In some embodiments, the anchoringmechanism can be an inflatable balloon designed to reduce functionalvolume of the stomach upon inflation and may be designed to include aport for inflating the anchoring mechanism. The anchoring mechanism, incertain embodiments, can also be a self-expanding frame which, uponexpansion, can be substantially frustoconical in shape for securingagainst a wall of the stomach while allowing the stomach to maintain asubstantially full functional volume. The device can further include apassageway extending through the anchoring mechanism and the sleeve, andalong which digested food can be directed from the stomach to the smallintestine. In addition to the device, the system can further include adelivery mechanism for directing the device to a site of implantation.The delivery mechanism, in an embodiment, can include a housing foraccommodating the device. The housing can be provided with a deliveryend, an opposing proximal end, and a passageway therebetween. In certainembodiments, the housing can be substantially tubular in shape and/ormade from a sufficiently flexible material for accommodating the device.The delivery mechanism, in an embodiment, can also include a deployingballoon, situated within the passageway of the housing, foraccommodating the sleeve of the device. The balloon may be provided withan open end attached to the delivery end of the housing and a closed endsituated within the housing, such that in the presence of positivepressure within the passageway of the housing, the balloon can beeverted from within the housing to direct the sleeve of the device intothe small intestine. A port, in an example, can be provided on thehousing through which positive pressure can be introduced into thehousing. The port, in an embodiment, can be provided with an inflationdevice detachably connected thereto. In addition, a gastroscope forguiding the system to the site of implantation can also be provided foruse in connection with the system of the present invention.

The present invention also provides, in another embodiment, a deliverymechanism. The delivery mechanism can include a housing. The housing canbe provided with a delivery end, an opposing proximal end, and apassageway therebetween. The delivery mechanism, in an embodiment, canalso include a deploying balloon, situated within the passageway of thehousing, for accommodating a sleeve of an implant device. The balloonmay be provided with an open end attached to the delivery end of thehousing and a closed end situated within the housing, such that in thepresence of positive pressure within the passageway of the housing, theballoon can be everted from within the housing to direct the sleeve ofthe device into the small intestine. In some embodiments, the housingcan be a reservoir capable of expanding to permit eversion of theballoon from within the passageway of the housing. In certainembodiments, the delivery mechanism can further include a port throughwhich positive pressure can be introduced into the passageway of thehousing to evert the balloon from within the passageway. To that end,the delivery mechanism may further include an inflation devicedetachably connected to the port and designed to introduce positivepressure into the housing via the port to deploy the implant device. Inaddition, a gastroscope for guiding the delivery mechanism to the siteof implantation can also be provided for use in connection with thedelivery mechanism of the present invention.

The present invention additionally provides, in another embodiment, amethod for providing bariatric therapy. The method can include evertinga sleeve from an inverted position into a small intestine. In anembodiment, positive pressure can be used to cause eversion of thesleeve. The method can further include anchoring the sleeve at itsproximal end adjacent a pyloric junction between stomach and mallintestine. The anchoring step, in an embodiment, can include securing ananchoring mechanism coupled to a proximal end of the sleeve within thestomach so as to allow the sleeve to securely extend into the smallintestine. The method, in some embodiments, can further include allowingdigested food to be directed from the stomach through the anchoringmechanism into the sleeve, while minimizing absorption of nutrients fromthe digested food by a wall of the small intestine. In addition, to theextend desired, the method can further include guiding the sleeve to asite of implantation with a gastroscope.

DESCRIPTION OF SPECIFIC EMBODIMENTS

In accordance with one embodiment of the present invention, a system isprovided herein for bariatric therapy. One system, as describedhereinafter, may be used to employ volume restriction within the stomachand/or enhance malabsorption within the small intestine. Such a systemof the present invention includes, in one embodiment, a gastrointestinalimplant device having an anchoring mechanism designed to be positionedwithin the stomach to anchor the device, and an intestinal sleeveattached at one end to the anchoring mechanism. The sleeve can bedesigned to extend along a portion of the small intestine to minimize orprevent nutrient absorption by the small intestine. In one embodiment,the anchoring mechanism may be a space occupying ring, an inflatableballoon, a self-expanding anchor or frame, or any combination thereof.As will be seen hereinafter, the system can also include a deliverymechanism for delivering or placing the device at a site ofimplantation.

Generally, food to be digested enters the stomach through the cardiacorifice from the esophagus. Once in the stomach, food is at leastpartially digested to produce chyme, a semi-fluid substance that can behomogeneous, creamy or gruel-like. Once produced, the chyme can thenexit the stomach through the pylorus or pyloric junction and enter thesmall intestine. The pylorus is a distal aperture of the stomachsurrounded by a strong band of circular muscle. The small intestine,about nine feet in length, is a convoluted tube, extending from thepylorus to the ileo-caecal valve where it terminates in the largeintestine. The small intestine has three sections including theduodenum, jejunum and the ileum.

The duodenum has four sections including the superior, descending,transverse and ascending sections which typically form a U-shape. Thesuperior section is about two inches long and ends at the neck of thegall bladder. The descending section is about three to four inches longand includes a nipple shaped structure (papilla of vater) through whichpancreatic juice from the pancreas and bile produced by the liver andstored by the gall bladder can enter the duodenum from the pancreaticduct. The pancreatic juice typically contains enzymes essential toprotein digestion and bile that can be used to dissolve the products offat digestion. The ascending section, on the other hand, is about twoinches long and forms the duodenal-jejunal flexure where it joins thejejunum, the next section of the small intestine. The duodenal-jejunalflexure is fixed to the ligament of Treitz (musculus supensionusduodeni). The juices secreted in the duodenum can break the partiallydigested food down into particles small enough to be absorbed by thebody.

Referring now to FIG. 1A, a system 100 for providing bariatric therapyaccording to one embodiment of the present invention is shown. System100 may include a gastrointestinal implant device 105 for facilitatingweight loss. In one embodiment, the device 105 can be used to reduce thesize of the stomach while simultaneously reducing absorption of foodnutrients within the small intestine. In accordance to an embodiment ofthe present invention, the device 105 may include an intestinal sleeve130 designed to extend from within the stomach and along a portion ofthe intestine below the pylorus, to minimize absorption of nutrients bythe intestinal walls.

As illustrated, the sleeve 130 may include a proximal end 132 that maybe designed for placement adjacent the pyloric junction, an area aroundthe pylorus where the stomach and the small intestine meet. The sleeve130 may further include a passageway 136 extending from the proximal end132 to allow passage of food and other food material through sleeve 130.As used herein, “food” or “other food material” can be usedinterchangeably; “food” can also include undigested, partially digested,and completely digested food. The sleeve 130 may further include adistal end 134. The distal end 134, in an embodiment, can be open-endedto provide an opening through which food and other food material canexit sleeve 130.

The sleeve 130, in an embodiment, can be designed to reduce absorptionand digestion of food by the intestinal walls. In particular, sleeve 130can line and cover the intestinal wall, and act to reduce absorption anddigestion of food by delaying the mixing of food with bile andpancreatic juices until after the food exits the distal end 134 ofsleeve 130. In other words, by preventing the mixing of bile andpancreatic juices with food in the duodenum, digested (partially orcompletely) food material is not broken down into particles small enoughto be absorbed by the body. As a result, the absorption of nutrients(e.g., fats and carbohydrates) is reduced.

To that end, the sleeve 130 can be made from any material that can aidin the passage of food through the sleeve 130. In one embodiment, thesleeve 130 can be made from a material that minimizes resistance andfriction so as to allow food to slide more easily through the sleeve.For instance, the sleeve 130 can be made from a material that issubstantially smooth and/or has a relatively low coefficient offriction. The sleeve 130 material may further have substantially lowpermeability to fluids to minimize the occurrence of digested foodleaking through the sleeve 130 and coming into contact with theintestinal wall where it can be absorbed. The sleeve 130 can also bemade from any material that helps to minimize or prevent tissuein-growth, as well as a material that can be non-irritating to thebowel, so as to aid in the removal of the sleeve 130, once removal isdesired. Since the sleeve 130 can be designed to be implanted within anintestine of a human or animal body, the sleeve 130 should also be madefrom a material that is biocompatible. The biocompatibility of thematerial may help minimize occurrence of adverse reactions due toconstant contact of the sleeve 130 with the gastrointestinal tract. Inan embodiment, the sleeve 130 can be made from any material that can beobtained commercially.

Should it be desired, sleeve 130 may further include a coating that canaid in reducing absorption of nutrients, minimize resistance to providea smooth passageway for food, minimizing porosity, preventing tissuein-growth, allowing subsequent removal of the device from the intestinaltract, or any other characteristic that may be desirable for the sleeve130. The coating may be applied to the sleeve 130 on an inner surface,an outer surface, or a combination thereof to minimize any porouscharacteristics of the sleeve material.

In one embodiment, the sleeve 130 can also be made from any materialthat allows the sleeve 130 to expand and collapse in accordance with thedigestive process. When food enters and passes through the sleeve 130,the sleeve material can be such that it may allow the sleeve 130 toexpand sufficiently to accommodate the digested food. Once the food fromthe stomach has passed through the sleeve 130, however, the sleevematerial can be such that is may allow the sleeve 130 to become flexibleor floppy, permitting the sleeve 130 to contour toward one side of theintestine. In this floppy state, the sleeve 130 may permit thepancreatic juice to flow with minimal resistance into the duodenumthrough the papilla of vater. Of course, in some instances, it may bedesirable for the sleeve 130 to maintain a substantially constant formthroughout the digestive process. In these instances, the sleeve 130 maybe made from a material that can maintain such a substantially constantform.

The length of the sleeve 130 may, in an embodiment, vary depending on avariety of characteristics. In certain instances, the length of thesleeve 130 may be dependent on the patient's Body Mass Index (BMI). Inother instances, the length of the sleeve 130 may be selected based onthe amount of absorption desired. A longer sleeve 130, for example, mayminimize absorption of nutrients by the intestinal walls over a longerdistance than a shorter sleeve 130. In some instances, the length of thesleeve 130 may be selected based on the distance necessary to bypass theduodenum and allow the sleeve 130 to couple with the jejunum. It shouldbe noted that the length of the sleeve 130 should also permit the sleeve130 to fit within the delivery mechanism 115 as well as within theintestine.

The sleeve 130 may have any shape desirable, so long as the shape allowsthe sleeve 130 to fit within the intestine. In one embodiment, thesleeve 130 may have a substantially tubular shape to allow the sleeve130 to substantially conform to the intestine. Of course, othergeometric shapes may be possible.

The sleeve 130 may further have any diameter desirable so long as thediameter allows food to travel through the sleeve 130 withoutsubstantial hindrance. In one embodiment, the sleeve 130 may have adiameter to allow the sleeve 130 to substantially conform to theintestinal walls when in an expanded state. By substantially conformingto the intestinal walls in an expanded state, the sleeve 130 canmaximize the amount of food traveling through. Of course, smallerdiameters may also be possible.

The gastrointestinal implant device 105 may further include, inaccordance with an embodiment of the present invention, an anchoringmechanism 140, coupled to the proximal end 132 of the sleeve 130. Theanchoring mechanism 140 may be designed to be positioned, in certaininstances, in the stomach to anchor the device 105 thereat. In anembodiment, the anchoring mechanism 140 can be an anchor that acts toreduce the functional volume of the stomach. An example of such ananchoring mechanism 140 can be a space occupying inflatable ring orballoon, or any other anchoring mechanism 140 adapted to adequatelyengage and secure the proximal end 132 of the sleeve 130 at the pyloricjunction, while reducing the volume of the stomach. In an embodiment,the anchoring mechanism 140 can be integral with the sleeve 130 at theproximal end 132, so that the anchoring mechanism 140 and sleeve 130 areformed from one piece of material. Alternatively, the anchoringmechanism 140 can be separate and independent from the sleeve so thatthe anchoring mechanism and sleeve 130 are formed from two pieces ofmaterial and are coupled to one another.

FIG. 1B shows the gastrointestinal implant device 105 in a deployedposition. In particular, the anchoring mechanism 140 is positioned at apoint within the stomach 145 just above the pylorus 149. The proximalend 134 of the sleeve 130, on the other hand, can extend from theanchoring mechanism 140 within the stomach 145, across the pylorus 149,and into the small intestine 147. It should be appreciated thatanchoring mechanism 140 can also extend into the pylorus 149 andproximal end 134 of the sleeve 130 can be situated adjacent the pylorus149. A passageway 150, in an embodiment, can extend through theanchoring mechanism 140 and the sleeve 130, so that food can be directedfrom the stomach 145, into the device 105 and moved along the passageway150, and into the small intestine 147.

As noted, the anchoring mechanism 140 can be designed, in certaininstances, to facilitate weight loss by reducing the functional volumeof the stomach 145. In other words, by occupying a portion of thestomach 145, the anchoring mechanism 140 can act to decrease thefunctional volume of the stomach 145, and thus, the amount of foodintake by the patient. To that end, The anchoring mechanism 140, in anembodiment, may have any size desirable, depending on the particularapplication, as the size of the anchoring mechanism 140 may affect thefunctional volume by which the stomach 145 is reduced. For instance, alarger anchoring mechanism 140 may occupy a larger space within thestomach and may, accordingly, reduce the functional volume of thestomach by a larger amount than a smaller anchoring mechanism. It shouldbe noted that the size of the anchoring mechanism 140 needs to permitthe anchoring mechanism 140 to be securely positioned within the stomachat a site of implantation. That is, the anchoring mechanism 140 can besufficiently large to prevent it from entry into the small intestine.

The anchoring mechanism 140, as illustrated in FIGS. 1A-1B, may have adonut shape. A donut shape may allow the anchoring mechanism 140 to bepositioned within the stomach, such that the anchoring mechanism 140 cansubstantially conform to the shape of the stomach and may,simultaneously, provide an exit for food to leave the stomach. Ofcourse, other shapes for the anchoring mechanism 140 may be possible.

To adequately secure the anchoring mechanism 140 within the stomach, theanchoring mechanism 140 can be made from a material that can radiallyexpand to exert a sufficient radial force to push the anchoringmechanism 140 against the walls of the stomach at the site ofimplantation. It should be appreciated that the material used shouldpermit the anchoring mechanism 140 to conform to the dimensions of thestomach at the implantation site, even when the dimensions of thestomach vary. In one embodiment, an anti-inflammatory agent such asdexamethasone, prednisolone, corticosterone, budesonide, estrogen,sulfasalazine, mesalamine, or any suitable combination or mixturethereof may be applied to the anchoring mechanism 140 to preventinflammation or any other adverse reaction caused by the engagement ofthe anchoring mechanism 140 within the stomach.

In accordance with one embodiment, as illustrated in FIGS. 1A-1B, theanchoring mechanism 140 may be provided with a port or valve 142 towhich an inflation mechanism may be detachably connected for inflationpurposes. To that end, the valve can be a one-way valve designed toprevent premature and unintentional deflation and removal of the device105 from the intestinal tract. The one-way valve may be an elastomericplug, a spring loaded valve, or any other valve known in the art as thepresent invention is not intended to be limited in this manner.

An inflation mechanism (not shown) for inflating the anchoring mechanism140 can include, for instance, an inflation catheter or any otherinflation device capable of inflating the anchoring mechanism 140. Asthe inflation mechanism can be detachably coupled to port or valve 142of the anchoring mechanism 140, the inflation mechanism can bedisconnected and detached from the port or valve 142 of anchoringmechanism 140 following inflation. It should be appreciated that theanchoring mechanism 140 can be deflated when removal of the device 105is desired.

Connection of the inflation mechanism to port or valve 142 of theanchoring mechanism 140 may occur, in certain embodiments, through theuse of a connector (not shown). The connector can act to couple theinflation mechanism to the anchoring mechanism 140 allowing theinflation mechanism to inflate the anchoring mechanism 140. In anembodiment, the connector may be situated on either the inflationmechanism or the anchoring mechanism 140. Alternatively, the connectormay include a two-piece design having two complimentary pieces to permitcoupling between the inflation mechanism and the anchoring mechanism140. Examples of connectors include a mating luer connector, a metaltube, or any other connectors known in the art.

Although an inflation mechanism is described herein, it should beappreciated that the anchoring mechanism 140 can be self-expanding toallow expansion of anchoring mechanism 140 without the aid of additionalinflation mechanisms. Such self-expanding mechanism, similar to a lifevest, are known in the art.

Still referring to FIG. 1A, system 100 for providing bariatric therapymay further include, in an embodiment, a delivery mechanism 115 fordelivering the gastrointestinal implant device 105 to a site ofimplantation. In an embodiment, the delivery mechanism 115 can include ahousing 110 having a delivery end 112, an opposing end 114, and apassageway 116 therebetween. In one embodiment, the delivery end 112 canbe designed to permit sleeve 130 of device 105 to be inserted (e.g., inan inverted position) into delivery mechanism 115. In addition, thedelivery end 112 may be sufficiently sized to permit anchoring mechanism140 to be securely positioned about delivery end 112.

In one embodiment, the housing 110 can be made from any material capableof passing through the intestine and delivering device 105 to a site ofimplantation. To that end, housing 110 may be formed from asubstantially hard material, so as to minimize deformation of thehousing 110 during delivery. Examples of materials that aresubstantially hard include metals, plastics, ceramics, or any othermaterials that can maintain a substantially consistent shape. Housing110 can also be made from a sufficiently flexible material to permitcompression of the housing 110. For example, housing 110 may be formedfrom a thin-walled membrane such as nylon laminated with polyurethane.

Since the housing 110 is designed to be inserted into an intestine of ahuman or animal body, the housing 110, in an embodiment, can be madefrom a material that is biocompatible. The biocompatibility of thematerial may help minimize occurrence of adverse reactions due to use ofthe housing 110 within an intestine. The housing 110 may further includea coating on an outer surface to reduce friction between the housing 110and the intestinal wall upon insertion into the intestine. Likewise, thehousing 110 may include a coating on an inner surface to reduce frictionduring deployment of the sleeve 130 situated within the housing 110.

It should be appreciated that the housing 110 may be provided with anyshape desirable, depending on the particular application, as the shapeof the housing 110 may affect ability of the housing 110 to deliver thedevice 105 to a site for implantation. For instance, housing 110 may betubular in shape. Housing 110, in other embodiments, may be triangularin shape. Of course, other shapes can be used as the present inventionis not intended to be limited in this manner.

The delivery mechanism 115, as shown in FIG. 1A, can also include adeploying balloon 120 for use in advancing the sleeve 130 of device 105from within housing 110 to the site of implantation (e.g., stomachand/or small intestine). The deploying balloon 120, in an embodiment,may include an open end 122 and a closed end 124, and may be providedwith a length sufficient to accommodate sleeve 130. In an embodiment,open end 122 of deploying balloon 120 can be provided with a tightfitting seal with the delivery end 112 of housing 110. By providing sucha seal at the delivery end 112 of housing 110 and by providing thedeploying balloon 120 with closed end 124, positive pressure can beintroduced into the housing 110 to evert the deploying balloon 120 fromwithin the housing 110, and to aid in deployment of the sleeve 130 fromthe deploying balloon 120. Of course, deploying balloon 120 and housing110 can be integral to each other (e.g., as a one-piece design) whereadditional seal may not be necessary to keep positive pressure in thehousing 110.

To deploy device 105 to a site of implantation, deploying balloon 120can be made from a material capable of withstanding a sufficient force,so as to permit eversion of the deploying balloon 120, and thusadvancement of the sleeve 130 from within the housing 110. In anembodiment, the deploying balloon 120 may be made from a thin-walledmembrane. For example, the deploying balloon 120 may be made from nylonlaminated with polyurethane or any similar materials. In an embodiment,the deploying balloon 120 may have a thickness ranging from about 0.05mm to about 0.09 mm. In an embodiment, the thickness of the deployingballoon 120 may be about 0.076 mm or 0.003 inches. The material of thedeploying balloon 120 may also be impermeable to fluids in order toallow the deploying balloon 120 to withstand sufficient positivepressure. Since the deploying balloon 120 is designed to be insertedwithin an intestine of a human or animal body, the deploying balloon 120can be made from a material that is biocompatible. The biocompatibilityof the material may help minimize occurrence of adverse reactions due touse of the deploying balloon 120 within an intestine.

As shown in FIGS. 2A-2B, the housing 110 and the deploying balloon 120can be integral with one another (FIG. 2A) or may be provided as twoseparated components (FIG. 2B). In the embodiment where housing 110 anddeploying balloon 120 can be integral with one another, housing 110 anddeploying balloon 120 can be made of the same material, e.g., acontinuous sheet of the same sufficiently flexible material. This way,no attachment or connection mechanism is required for connecting housing110 and deploying balloon 120. Suitable materials include withoutlimitation, plastics, rubber, polymers, resin, cloth, and so on.Alternatively, in the embodiment where housing 110 and deploying balloon120 can be two separate components, housing 110 and deploying balloon120 can be made of different materials. For example, housing 110 can bemade of a sufficiently rigid material, while the deploying balloon 120being made of a sufficiently flexible material. Of course, the samematerial can be used for both the housing 110 and the deploying balloon120. Suitable attachment or connection mechanism known in the art mayalso be provided, to the extent desired, so as to connect housing 110and deploying balloon 120.

As shown in FIG. 2A, the housing 110 can have a diameter substantiallysmaller than that of the deploying balloon 120. In one example, thediameter of the housing 110 can be about half of the deploying balloon120 while still able to accommodate the deploying balloon 120. In otherexamples (e.g., FIG. 2B), the housing 110 can have a diameter that islarger than that of the deploying balloon 120. It should be noted thatFIGS. 2A-2B illustrate the deploying balloon 120 in its everted ordeployed position, and that before eversion or deployment, the deployingballoon 120 can be inverted for placement within the housing 110. Ofcourse, the diameter of the housing 110 and deploying balloon 120 mayremain substantially constant throughout.

It should be appreciated that regardless of the size of the housing 110relative to that of the deploying balloon 120, the diameter of eachshould be sufficient to accommodate the sleeve 130. It should beappreciated that the length of the housing 110 should permit thedelivery mechanism 115 to be inserted into an intestine and advancedalong the intestine to a site for implantation.

The housing 110, in an embodiment, may have any shape desirable,depending on the particular application, as the shape of housing 110 canfacilitate delivery of the device 105 to a site for implantation. Forinstance, housing 110 may be tubular in shape. Of course, other shapescan be used as the present invention is not intended to be limited inthis manner.

In accordance with one embodiment, the delivery mechanism 115 canfurther include an inflation mechanism (such as inflation device 250shown in FIG. 4) for introducing positive pressure into the housing 110,so as to cause eversion of the deploying balloon 120 from within thehousing 110. Suitable inflation mechanism can include, for instance, aninflation catheter, a pump, or any other inflation device capable ofintroducing positive pressure the housing 110. As the inflationmechanism can be detachably coupled to the housing 110, the inflationmechanism can be disconnected and detached from the housing 110following inflation. Connection of the inflation mechanism to thehousing 110 may be achieved using any method known in the art.

In order to introduce positive pressure into housing 110 through the useof an inflatable mechanism, the system 100 of the present invention maybe provided with an inflation port 170 in the housing 110 through whichfluids (e.g., air, liquids, gas or other substances) can enter withsufficient positive pressure to evert deploying balloon 120 andsubsequently deploy the gastrointestinal implant device 105. In oneembodiment, inflation port 170 can be situated at end 114 of housing110. Of course, other locations for the inflation port 170 may bepossible, as long as fluids can enter with a sufficient force to deploythe device 105.

Now referring to FIGS. 3A-3B, the system 100 of the present inventioncan be used in connection with a gastroscope 160, 160′. The gastroscope160, 160′ may help guide the system 100 through the gastrointestinaltract. In an embodiment, the gastroscope 160 in FIG. 3A may be providedwith a body designed to be situated about or adjacent the housing 110.The gastroscope 160 may also be provided with tip 162 to be positionedagainst a surface of the anchoring mechanism 140. In such an embodiment,the anchoring mechanism 140 may be constructed of transparent materialto allow visualization out the end of the gastroscope 160 as shown inFIG. 3A. No X-ray exposure or any other mechanism may be needed to helpdeploy the gastrointestinal implant device 105 of the present invention.Should it be desired, delivery mechanism 115 and device 105 may includean opaque substance to permit visualization by a user duringimplantation.

In certain embodiments, the system 100 of the present invention may bedesigned to allow a gastroscope 160′ to help guide the system 100through the intestinal tract. As shown in FIG. 3B, gastroscope 160′ maybe used with the deploying balloon 120′ and sleeve 130′ in their evertedor deployed position to help guide the sleeve 130′ to its desiredlocation (e.g., to further extend along the small intestine). Thegastroscope 160′, as shown, may be positioned through the housing 110and beyond and designed to maintain the stability of the system 100 asthe system 100 is advanced along the gastrointestinal tract. It shouldbe noted that while the gastroscope 160 can be positioned in any mannerto allow guidance of the system 100, its design should minimize anyobstructions of the deploying balloon 120 and sleeve 130 from everting.In an embodiment, the gastroscope 160 may be any guidewire that iscommercially available.

Looking now at FIGS. 4-6, there are illustrated alternative system ofthe present invention. As illustrated, system 200 can be used to providebariatric therapy. System 200, in an embodiment, can include a deliverymechanism 215 and an implant device 205. In accordance with theembodiments shown in FIGS. 4-6, delivery mechanism 215 may besubstantially similar to the delivery mechanism 115 described above, butthe housing 110 delivery mechanism 215 may be a reservoir 210 for use inconnection with the deployment of the device 205. Such a housing 210 canallow the delivery mechanism 215 to reside in different organs, such asthe stomach in a patient, in addition to being inserted into theintestine. The delivery mechanism 215, in accordance with oneembodiment, may include a reservoir 210 for use in connection withimplantation of device 205. In one embodiment, the reservoir 210 mayserve substantially the same functions as housing 110 in that thereservoir 210 can be used to accommodate at least a part of the device205 and deliver the device 205 to a site for implantation. Reservoir210, if desired, may be designed to accommodate sleeve 230 in reservoir210 and may be designed to facilitate eversion of sleeve 230.

In an embodiment, the reservoir 210 can be made from a material that canbe sufficiently strong to allow the reservoir 210 to be directed withinthe body of a patient without rupturing. The material, in an embodiment,can also be sufficiently flexible to allow the reservoir 210 to expandand collapse during deployment of the device 205.

The reservoir 210 may have any shape, as long as the shape can fitwithin the intestine or esophagus for delivery. In an embodiment, thereservoir 210 can be substantially circular in shape and can be expandedto any shape desired. In another embodiment, the reservoir 210 can betubular in shape. Of course, other shapes are possible. The reservoir210, in another embodiment, may have a size and/or length sufficient toaccommodate balloon 220 and/or sleeve 230. As shown in FIG. 5A, the sizeand/or length of the reservoir 210 may be such that it may accommodateballoon 220 and/or sleeve 230 in a folded or rolled up manner.

The reservoir 210 may also be provided with any size desirable, as thesize the reservoir 210 may facilitate delivery of device 205 and sleeve230. For example, a smaller sized reservoir 210 may be used to deliverdevice 205 through an individual's esophagus, while a larger one may notbe able to fit through an esophagus.

The delivery mechanism 215, in an embodiment, may further include adeploying balloon 220, similar to deploying balloon 120, for use inplacement of the device 205 at the site of implantation within thegastrointestinal tract. It should be noted that the length and shape ofthe deploying balloon 220 should be such that the balloon 220 can fit(e.g., in a folded or rolled up manner), at least partially within thereservoir 210. In an embodiment, the balloon 220 can be attached to orpositioned about an end of the reservoir 210 at its open end 222.

A sleeve 230 may be stored (e.g., in an inverted state) within deployingballoon 220 similar to the manner in which the sleeve 130 can be storedwithin deploying balloon 120 and housing 110, as described above. In anembodiment, the sleeve 230 may be stored in a folded state such as shownin FIG. 5A or may be stored in a rolled up state. Of course, the sleeve230 may be stored in other manners so long as it fits, at leastpartially within the reservoir 210. An anchoring mechanism 240 foranchoring and securing device 205 to a site of implantation, similar tothe one described above, may be situated at the proximal end 232 ofsleeve 230, as shown in FIG. 4.

To deploy the gastrointestinal implant device 205, an inflation device250 may be connected to the reservoir 210. The inflation device 250, inan embodiment, may be designed so as to permit insertion of thegastrointestinal implant device 205 through the esophagus of a patient.In an embodiment, the inflation device 250 can be sufficiently thin andnarrow. A seal 280, can be provided at the end of the inflation device250, as desired, to minimize leakage of fluid being introduced byinflation device 250.

FIGS. 5A, 5B, and 6 show the use of a gastroscope 260 to help guide thesystem 200 through the intestinal tract to a site of interest. Thegastroscope 260, as shown in FIG. 5A, can be positioned through theinflation device 250 and the reservoir 210. In another embodiment shownin FIG. 6, gastroscope 260′ can extend to reservoir 210 without goingthrough the inflation device 250. It should be noted that FIGS. 5B and 6show the system 200′ in a fully deployed state, with the deployingballoon 220′ and sleeve 230′ in their everted position.

To prepare the system 100 for insertion in the body, a user caninitially position a deploying balloon 120 within housing 110 ofdelivery mechanism 115. In one embodiment, the open end 122 of thedeploying balloon 120 can be situated adjacent or attached to thedelivery end 112 of the housing 110, and the closed end 124 of thedeploying balloon 120 can be situated adjacent the opposing end 114 ofthe housing 110. An open ended sleeve 130 may then be placed withincavity 126 of deploying balloon 120 with the open ended distal end 134of the sleeve 130 situated adjacent the closed end 124 of the deployingballoon 120, while the proximal end 132 of the sleeve 130 situatedadjacent the open end 122 of the deploying balloon 120. Additionally,anchoring mechanism 140, being coupled to the proximal end 132 of thesleeve 130, can be positioned about the delivery end 112 of the housing110.

Once loaded, the system 100 may be inserted into the body, and advancedalong the intestine within the body to a site of interest forimplantation. A gastroscope 160 may be used to help guide the system 100through the intestinal tract to a site of implantation. In anembodiment, a guidewire (not shown) may be used to maintain thestability of the system 100 as the system 100 advances through thetract. Once at the site of implantation, the system 100 can be preparedfor deploying the device 105. Implantation may first require theanchoring mechanism 140, attached to the proximal end 132 of the sleeve130, to be inflated using an inflation mechanism. Inflation of theanchoring mechanism 140 can act to hold the gastrointestinal implantdevice 105 in a desired position during the eversion process. Forexample, the anchoring mechanism 140 can be placed within the stomach orin the small intestine adjacent the pyloric junction. After theanchoring mechanism 140 is anchored at the site of interest, the sleeve130 may be everted. Eversion may require the direction of pressurized orunpressurized fluid (e.g., gas, liquid, or a combination thereof) intohousing 110 via inflation port 170. As fluid is directed into housing110, the fluid acts to evert and advance deploying balloon 120 fromwithin housing 110, while pushing sleeve 130 from housing 110 along withdeploying balloon 120, as shown in FIG. 3B. In some embodiments, thesleeve 130 is a shorter length than the deploying balloon 120, which canallow complete delivery of the sleeve 130 upon full eversion ofdeploying balloon 120.

FIG. 7-8 show the deploying balloon 120 and sleeve 130 of the system 100in partial eversion and subsequent deployment upon full eversion. InFIG. 7, gastrointestinal implant device 105′ is in the process of beingeverted from within the passageway 116 of the housing 110, whereeverting deploying balloon 120′ pushes and everts the sleeve 130′ fromtherewithin. The everting deploying balloon 120′, thereafter, candistend the intestine as it is deploying the everting sleeve 130′, andcan automatically follow the course of the bowel. FIG. 8 shows theimplant device 105″ in a fully deployed state, with everted deployingballoon 120″ extending beyond the everted sleeve 130″. With thegastrointestinal implant device 105″ deployed and engaged within theintestinal wall, food and other food material can be passed from thestomach through the everted sleeve 130″.

In accordance with the embodiments depicted in FIGS. 4-6, the method ofdeploying device 205 using a reservoir 210 may be substantially similarto the method described above with several changes to reflect the use ofa reservoir 210. Once loaded into the reservoir 210, system 200 may beinserted into the body, and advanced along the intestine within the bodyto a site of implantation. A gastroscope 260 may be used to guide thesystem 200 through the gastrointestinal tract. Implantation may firstrequire the anchoring mechanism 240, attached to the proximal end 232 ofthe sleeve 230, to be inflated using an inflation mechanism. After theanchoring mechanism 240 is anchored to the stomach or small intestine atthe site of implantation, the device 205 may be everted. Eversion mayrequire activation of the inflation device 250, which can result in thereservoir 210 being inflated, as shown in FIG. 5A. Inflation of thereservoir 210 can cause the reservoir 210 to enlarge and/or becomepressurized, allowing the balloon 220 to evert and deploy the device205. FIGS. 5B and 6 show embodiments of the system 200 in a fullydeployed state. In an embodiment, the reservoir 210 can provide a lowfriction compartment for everting the balloon 220 and sleeve 230.

Following deployment of the sleeve 130, the deploying balloon 120 can bedeflated and a vacuum can be drawn to constrict the deploying balloon120. Constriction of the deploying balloon 120 can allow the deployingballoon 120 to be pulled out of the sleeve 130, leaving the sleeve 130in position within the intestine. Since the diameter of the deployingballoon 120 can be less than the diameter of the sleeve 130, deployingballoon 120 withdrawal is performed upon deflation and formation of avacuum in the deploying balloon 120. As previously stated, a coating orlubrication may be placed between the sleeve 130 and the deployingballoon 120 during manufacture, to ensure easy deploying balloon 120removal.

With reference now to FIGS. 9-13, there are illustrated anotherbariatric therapy system 300 in accordance with an embodiment of thepresent invention. System 300, in an embodiment, can include a deliverymechanism 315 and an implant device 305. As shown in FIGS. 9-13, thedelivery mechanism 315 may be substantially similar to the deliverymechanism 115, 215 described above, but no separate housing may benecessary to deploy the device 305. The delivery mechanism 315, in anembodiment, may include a deploying balloon 320, similar to deployingballoon 120 and housing 110 in the embodiments described above, for usein the placement of device 305 at the site of implantation within thegastrointestinal tract. It should be noted that the length and shape ofthe deploying balloon 320 should be such that the balloon 320 can fitwithin the intestinal track. In an embodiment, the deploying balloon 320may be formed from a continuous piece of material as shown in FIG. 9A.The deploying balloon 320 may also be formed from a soft and flexiblematerial such that upon inflation of the balloon 320, the pressuretherein can allow the device 305 to be advanced through the intestinaltrack. The material from which deploying balloon 320 can be made canalso be inelastic to withstand a sufficient pressure for deploying thedevice 305. In an embodiment, the deploying balloon 320 may be formedfrom a single thin-walled membrane. For example, the deploying balloon320 may be made from nylon laminated with polyurethane. In anembodiment, the deploying balloon 320 may have a thickness ranging fromabout 0.05 mm to about 0.09 mm. In an embodiment, the thickness of thedeploying balloon 320 may be about 0.076 mm or 0.003 inches.

Referring still to FIG. 9A, the delivery mechanism 315, in anembodiment, may further include a sleeve 330 that may be positionedwithin deploying balloon 320, similar to the manner in which the sleeve230 can be stored within deploying balloon 220, as described above. Thesleeve 330, in one embodiment, may be formed from a membrane that can beless thick than the thickness of the membrane used to form the deployingballoon 320. In an example, the sleeve 330 may be approximately 0.025 mm(0.001″) in thickness. The materials from which sleeve 330 may be formedincludes without limitation, polyethylene, polyvinyl chloride, nylon,polyethylene terephthalate, or other polymer. The relative thickness ofthe intestinal sleeve 330 compared to the deploying balloon 320 can beimportant, as such thickness can provide less friction during eversionof the sleeve 330 and the deploying balloon 320. In one example, when asleeve material has a thickness less than the thickness of the balloonmaterial, air eversion may be possible and the everting structure may besufficiently soft to advance through tortuous bowel. In one embodiment,a sleeve material can have a thickness that is about one-third of thethickness of the balloon material. In other examples, when a sleevematerial has a substantially similar thickness to that of the balloonmaterial, friction between the membrane layers may cause inflationpressure to rise to a sufficiently high level, such that anincompressible fluid (water or saline) may be required to deploy thesleeve 330. This may, in turn, cause increased rigidity of the evertingclosed ended balloon 320.

The device 305 may further include an anchoring mechanism 340 foranchoring and securing device 305 to a site of implantation. In anembodiment, anchoring mechanism 340 may be situated at proximal end 332of sleeve 330. Anchoring mechanism 340 may be designed to beself-expanding and/or with a minimal profile so that when it ispositioned within the stomach, the anchoring mechanism 340 can allow thestomach to retain substantially its full functional volume. Inaccordance with the embodiments shown in FIGS. 9-13, the anchoringmechanism 340 may be a self-expanding anchor or frame, for securingagainst the stomach wall. The anchoring mechanism 340, as shown in FIG.10, may be a thin structure that can be designed to expand immediatelyproximal to the pylorus, and remains in the stomach, to allow theintestinal sleeve 330 to extend into the small intestine (e.g., into theduodenum and jejunum). The proximal end 332 of sleeve 330, in someembodiments, may be situated within the stomach just above the pylorus.

The anchoring mechanism 340, in one embodiment, may be constructed ofspring metal, such as stainless steel, or it may be formed of a rigidplastic, such as polyurethane or polyethylene or polyethyleneterephthalate. The anchoring mechanism 340 may be processed to haveshape memory properties. The anchoring mechanism 340 may also bedesigned to present a smaller packing profile, as a thin frame canoccupy less space than multiple layers of membrane in an inflatableanchor, and may present less obstruction to outflow of stomach contents.

The system 300 may also be designed to accommodate a gastroscope 360.The gastroscope 360 may be used to provide or enhance columnal strengthfor advancement of the device into the duodenum in preparation fordeployment of the intestinal sleeve in the bowel. In an embodiment, thegastroscope 360 can be a part of the system 300. The gastroscope 360 maybe constructed from a plastic material such as polyethylene,polyethylene terephthalate, polyvinyl chloride, polyurethane,polytetrafluoroethylene (Teflon), or any other known strong material. Inan embodiment, the gastroscope 360 may contain fiber or wire strands orbraid for reinforcement. FIG. 11 shows a system 300 having gastroscopetube 380, gastroscope 360, anchor 340, and inverted deploying balloon320 and sleeve 330.

The gastroscope 360, in an embodiment, may be provided within agastroscope tube 380. The gastroscope 360 and/or tube 380 may be coupledto the deploying balloon 320, for example, through the use of a couplingmechanism 335, so as secure the device 305 thereto. The deployingballoon 320 may also be bonded to the gastroscope 360 and/or tube 380 toform a compact unit. The bonding, in an embodiment, can be along oneline axially. In some embodiments, the gastroscope 360 and/or tube 380may be coupled to the deploying balloon 320 through the use of anadhesive, such as glue or tape. In other embodiments, the gastroscopetube 360 and/or 380 may be coupled to the deploying balloon 320 throughthe use of a nail, screw, clip or other coupling mechanism 335 capableto bonding the gastroscope tube 360 and/or 380 to the balloon 320. Ofcourse, those skilled in the art may appreciate that other couplingmechanisms 335 may also be possible as the present invention is notintended to be limited in this manner.

The gastroscope 360 may also contain a connecting mechanism 342, asshown in FIGS. 13A and 13B, for holding the anchoring mechanism 340 inposition during deployment of the intestinal sleeve. The connectingmechanism 342 may be designed to couple the deploying balloon 320 to thegastroscope 360. In one embodiment, the connecting mechanism 342 mayinclude a suture 343 to couple the deploying balloon 320 to thegastroscope 360. An opening in the side of the gastroscope 360 may beprovided to allow the suture 343 to pass therethrough. As shown in FIG.13B, the suture 343 may run the length of the gastroscope 360, out theside opening, through a loop in the anchoring mechanism 340, and end ata proximal port, to secure the anchoring mechanism 340 to thegastroscope 360. In an embodiment, the suture 343 may be designed sothat it can be severed and removed so as to release the anchoringmechanism 340 and sleeve 330 following deployment. In anotherembodiment, the connecting mechanism 342 may further be designed toprovide reference positioning for intestinal sleeve deployment.

The system 300 of the present embodiment may further include a sheath310, as shown in FIGS. 12A-12C, designed to for placement over theanchoring mechanism 340, the proximal end of deploying balloon 320, andthe proximal end of the sleeve 330. The sheath 310 may be made from asemi-flexible material with a length sufficient to cover substantiallythe entire length of the anchoring mechanism 340. Of course, the lengthof sheath 310 can be varied according to specific designs. In anembodiment, sheath 310 can be sufficiently long so as to coversubstantially the entire length of the deploying balloon 320 and sleeve330. A wire 365 may be coupled to the sheath 310 and may extendsubstantially along the length of the device 305 or beyond. The wire 365may be designed to be pulled, so as to withdraw the sheath 310 (prior todeployment of the sleeve 330) as illustrated in FIG. 12C, with theanchoring mechanism 340 in an expanded state.

To deploy the gastrointestinal implant device 305, as shown in FIG. 9B,delivery mechanism 315 of system 300 may be provided with an inflationport 370. In an embodiment, the inflation port 370 may be designed toallow fluids (e.g., air, liquids, gas or other substances) to enter withsufficient pressure to evert deploying balloon 320 and deploy thegastrointestinal implant device 305. In one embodiment, inflation port370 can be coupled to deploying balloon 320. Of course, other locationsfor the inflation port 370 are possible as long as fluids can enterdelivery mechanism 315 with a sufficient force to deploy the device 305.

To prepare the delivery mechanism 315 for insertion in the body, a usercan initially position an open ended sleeve 330 within deploying balloon320. In an embodiment, the proximal end 332 of the sleeve 330 may besituated adjacent the open end 322 of the deploying balloon 320, whilethe distal end 334 of the sleeve 330 may be situated adjacent the closedend 324 of the deploying balloon 320. Additionally, anchoring mechanism340, can be coupled to the proximal end 332 of the sleeve 330. The openended sleeve 330, deploying balloon 320 and anchoring mechanism 340, inone embodiment, may be compressed and encased within sheath 310.

Once loaded, the delivery mechanism 315 may be inserted into the body,and advanced along the intestine within the body to a site of interestfor implantation. The gastroscope 360 may be used to help guide thedelivery mechanism 315 through the intestinal tract to a site ofimplantation. In an embodiment, a guidewire (not shown) may be used tomaintain the stability of the delivery mechanism 315, as the deliverymechanism 315 advances through the tract. Once at the site ofimplantation, the delivery mechanism 315 can be prepared for deployingthe device 305. Deployment may first require removal of the sheath 310by pulling wire 365 to withdraw the sheath 310, prior to deployment ofthe sleeve 330, which may act to cause subsequent expansion of theanchoring mechanism 340. Expansion of the anchoring mechanism 340 canact to hold the gastrointestinal implant device 305 in a desiredposition during the eversion process. After the anchoring mechanism 340is anchored to the stomach wall or intestinal wall at the site ofinterest, the sleeve 330 may be everted from within the deployingballoon 320. Eversion may require activation of the inflation port 350,which can result in the deploying balloon 320 being inflated. Inflationof the deploying balloon 320 can cause the deploying balloon 320 toenlarge and/or become pressurized, allowing the deploying balloon 320 toevert and deploy the device 305. In an embodiment, the deploying balloon320 can provide a low friction compartment for everting the sleeve 330.With the gastrointestinal implant device 305 deployed and engaged withinthe intestinal wall, food and other food material can be passed throughthe sleeve 330.

Following deployment of the sleeve 330, the gastroscope 360, deployingballoon 320 and sheath 310 can be removed from the body. For example,the suture 343 may be severed and removed so as to release the anchoringmechanism 340 and sleeve 330 following deployment. In an embodiment, thedeploying balloon 320 may be constricted to allow the deploying balloon320 to be pulled out of the sleeve 330, leaving the sleeve 330 inposition within the intestine. Since the diameter of the deployingballoon 320 can be less than the diameter of the sleeve 330, deployingballoon 320 withdrawal may be performed upon deflation and formation ofa vacuum in the deploying balloon 320. As previously stated, a coatingor layer of lubrication may be placed between the sleeve 330 and thedeploying balloon 320 during manufacture, to ensure easy deployingballoon 320 removal.

While the invention has been described in connection with the specificembodiments thereof, it will be understood that it is capable of furthermodification. Furthermore, this application is intended to cover anyvariations, uses, or adaptations of the invention, including suchdepartures from the present disclosure as come within known or customarypractice in the art to which the invention pertains, and as fall withinthe scope of the appended claims.

What is claimed is:
 1. A delivery mechanism comprising: a housing havinga delivery end, an opposing proximal end, and a passageway therebetween;a deploying balloon having an open end attached to the delivery end ofthe housing and a closed end inverted within the passageway of thehousing, the balloon designed to accommodate a gastrointestinal implantdevice and capable of being everted from within the passageway of thehousing so as to direct the implant device to a site of implantation;and a port through which positive pressure can be introduced into thepassageway of the housing to evert the balloon from within thepassageway.
 2. The delivery mechanism of claim 1, wherein the housing isa reservoir capable of expanding and collapsing, which, upon expansion,is capable of causing eversion of the balloon from within the passagewayof the housing.
 3. The delivery mechanism of claim 1, wherein thehousing is substantially tubular in shape.
 4. The delivery mechanism ofclaim 1, wherein the balloon is made from a material capable ofwithstanding a sufficient force so as to permit eversion of the balloonfrom within the passageway of the housing and eversion of the implantdevice from within the balloon.
 5. The delivery mechanism of claim 1,further including an inflation device detachably connected to the portand designed to introduce positive pressure into the housing via theport to deploy the implant device.
 6. The delivery mechanism of claim 1,further including a gastroscope for guiding the delivery mechanism tothe site of implantation.
 7. A method for providing bariatric therapycomprising: everting a sleeve from an inverted position into a smallintestine; anchoring the sleeve at its proximal end adjacent a pyloricjunction; and allowing digested food to be directed from the stomachthrough the anchoring mechanism into the sleeve, while minimizingabsorption of nutrients from the digested food by a wall of the smallintestine.
 8. The method of claim 7, wherein the everting step includeseverting an inverted balloon within which the inverted sleeve isaccommodated.
 9. The method of claim 7, wherein the everting stepincludes introducing positive pressure into the housing to causeeversion of the deploying balloon from within the housing and eversionof the sleeve from within the deploying balloon.
 10. The method of claim7, wherein the anchoring step includes securing an anchoring mechanismcoupled to a proximal end of the sleeve within the stomach so as toallow the sleeve to securely extend into the small intestine.
 11. Themethod of claim 10, wherein in the anchoring step, the anchoringmechanism is an inflatable balloon sufficiently large to prevent theinflatable balloon from entry into the small intestine and to reduce thefunctional volume of the stomach in an inflated state.
 12. The method ofclaim 10, wherein in the anchoring step, the anchoring mechanism is aself-expanding frame which, upon expansion, is substantiallyfrustoconical in shape for securing against a wall of the stomach whileallowing the stomach to maintain a substantially full functional volume.13. The method of claim 7, further including guiding the sleeve to asite of implantation with a gastroscope.